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Fasting Mimicking Diet for Reducing Immunotherapy Side Effects

This study, called the FMD-ICI Trial, is looking at whether a special diet called a Fasting Mimicking Diet (FMD) can help reduce side effects for cancer patients receiving immunotherapy. Immunotherapy, which includes drugs like nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, and ipilimumab, can sometimes cause the immune system to become overactive, leading to issues like skin rash, diarrhea, and fatigue. The FMD is a restrictive calorie diet designed to mimic fasting and potentially protect patients from these side effects. The study aims to see if this diet can improve your well-being and quality of life. You may be eligible if you are an adult with advanced solid cancer (stage 3 or 4) and are receiving one of the specified immunotherapy treatments.

Study design
This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved
You will receive nutrition counseling, follow the FMD for 4 days during 3 cycles of immunotherapy, and receive educational guidelines. Blood samples will be collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up for 6 months after completing the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06438588

Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial

Terminated
NAAges 18+InterventionalSupportive care
Mayo Clinic
~2 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDietary InterventionEducational InterventionElectronic Health Record ReviewInterviewNutritional Assessment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptom Measurement
Measured over Up to 6 months
+4 more outcomes measured

Conditions

Advanced Malignant Solid Neoplasm

Explore related trials

Solid Neoplasm

NCT06438588

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Florida

    Jacksonville, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Francis A. Farraye, MD, MS · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Patients undergoing immunotherapy regardless of prior immunotherapy history
Age ≥ 18 years
Body mass index (BMI) \> 19
Histological confirmation of advanced staged malignancies (stage 3 or 4) appropriate for the following types of immunotherapy: PD-1 Antibody (nivolumab, pembrolizumab), PD-L1 Antibody (atezolizumab, avelumab, durvalumab), CTLA-4 Antibody (ipilimumab) or any combination thereof

Exclusion

Age \< 18 years
Pregnant women
Nursing mothers
Persons of childbearing potential who are unwilling to employ adequate contraception
Patients will be excluded if they are on insulin due to diabetes \[diabetic patients will be asked to monitor their glucose levels with a continuous glucose monitoring (CGM) device\], if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression

What this trial measures

  • Symptom MeasurementUp to 6 months

    Symptoms will be measured using a modified version of the Memorial Symptom Assessment Scale. The modified version will contain specific items related to side effects of immune checkpoint inhibitors (ICIs) including twelve GI symptoms, skin changes, and fatigue. The scale includes 24 items for which the participant reports on whether a symptom (e.g., pain, lack of energy, shortness of breath) occurred during the previous week, as well as any distress it may have caused. Questions are answered on a 0-4 or 0-4 scale (e.g., 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost Constantly).

  • Incidence of adverse eventsUp to 6 months

    Will grade the severity of symptoms using the CTCAE v3.0 scale. Will report descriptive analysis of rates and means. Patients will also be asked to report on any incidences of involuntary fasting due to their symptoms.

  • Physical functionUp to 6 months

    Physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, a 10-item measure of mobility and extremity function that was specifically developed for use in cancer, populations. Items are scored from 1-5 each with higher scores indicating better physical function.

  • Quality of life - FACT-GUp to 6 months

    Quality of life will be measured using the seven item Functional Assessment of Cancer Therapy (FACT-G), an abbreviated version of the FACT-G. Each item is scored from 0 (not at all) to 4 (very much). Higher overall scores correspond with better quality of life.

  • Fecal calprotectinAt baseline, week 12 and week 24

    Fecal calprotectin will be measured by patients who develop diarrhea or the gastrointestinal side effects. Will be obtained as standard of care to assess for immune mediated colitis if CTCAE v3.0 score is greater than 1.